IP NEWS

Canadian Patent Office Updates Examination Guidelines for Antibodies

16/03/2017

In January, 2017, The Canadian Intellectual Property Office (CIPO) updated a portion of the Manual of Patent Office Practice (MOPOP) examination guidelines which address the requirements for patenting antibodies. The updates, contained in section 17.07 of MOPOP, are intended to reflect the current state of the art in the antibody field.

MOPOP serves as an administrative guideline for patent examiners and describes application formalities as well as CIPO’s interpretation of substantive aspects of patent law. It takes on a particular importance in Canadian patent prosecution, due to the dearth of judicial decisions in several areas of patent law, including biotechnology.

Section 17.07 provides guidance on issues of anticipation, novelty, utility and support for claims directed to antibodies, including polyclonal, monoclonal, chimeric and humanized antibodies. It states that the field has advanced sufficiently that in general, a sufficient disclosure of a specific antigen, including a full characterization, presumptively supports a claim directed to an antibody for that antigen, even if there are no examples describing production of the antibody. In the case of a polyclonal antibody, the presumption normally applies if there is nothing peculiar about the disclosed antigen and that a skilled person would assume that an antibody against that antigen could be generated by conventional means. However, the presumption can be rebutted, especially for monoclonal, chimeric or humanized antibodies. In such cases, a description of the antigen may be insufficient to support a claim to the antibody if there are, for example, a) indications in the art or the patent specification that a skilled person would have encountered difficulties in producing the antibody, b) the inventor has suggested an inability to produce the antibody, or c) there are other indications that undue experimentation or undue modification of known steps would be required to generate the antibody.

The presumption of sufficient description can also be rebutted if a claimed antibody is said to have unique functional characteristics that go beyond simple interaction with the target antigen or the target antigen is particularly complex.

The antigen may be described by a complete characterization or, in the case of monoclonal antibodies (including chimeric and humanized antibodies), by depositing a hybridoma that produces the antibody in a recognized depositary. However, a deposit might not support a claim directed to DNA that encodes the binding portion of an antibody.

Issues of novelty and obviousness can also turn on the nature of the antigen. If the antigen is new and inventive, then the antibody will likely be considered patentable. Even if the antigen is known or obvious, the antibody can be patentable if inventive ingenuity or undue experimentation was required to produce the antibody. As well, if the antigen is known, it can still be possible to claim an antibody generated by a specific hybridoma which has been deposited.

As with other biological and pharmaceutical inventions, the “utility” requirement can present difficulties for antibody inventions. In general, if the specification does not “promise” any specific utility, only “a mere scintilla” of utility is required, for example a research use. However, if the description promises a higher level of utility, such as specific therapeutic results, then this use must be either demonstrated or soundly predicted by way of sufficient data or other information.

The revised guidelines also provide useful examples of patentable and unpatentable claims which illustrate these principles.